Leniolisib is a Pharming Group N.V. program in activated PI3K-delta syndrome (APDS), children aged 4 years and older weighing 13 kg or more (lower-dose formulation). Its next catalyst is a Readout in Nov 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Leniolisib is marketed as Joenja (leniolisib); the events below include those tracked under the brand name. FDA approval tracked on pdufa.bio: activated PI3K-delta syndrome (APDS) in children (resubmission covering patients weighing 27 kg or more) (approved Sep 11, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Indication under review: Activated PI3K-delta syndrome (APDS), children aged 4 years and older weighing 13 kg or more (lower-dose formulation). Sponsor: Pharming Group N.V. (PHAR). Review status: Supplemental NDA for lower doses of Joenja, accepted with Priority Review (6-K of September 25, 2026). Follows the September 11, 2026 approval for children aged 4 to 11 weighing at least 27 kg. Market-cap tier at the time we tracked it: Small. We track 3 catalyst events for this program: 2 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
The next tracked catalyst for Leniolisib is a Readout in Nov 2026.
On Sep 11, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Leniolisib is FDA-approved for activated PI3K-delta syndrome (APDS) in children (resubmission covering patients weighing 27 kg or more) (approved Sep 11, 2026), and under review or in development for Activated PI3K-delta syndrome (APDS), children aged 4 years and older weighing 13 kg or more (lower-dose formulation). Other approved uses may not be tracked here; the FDA label is the full record.
Pharming Group N.V. (PHAR).
Yes. The FDA approved an application for Leniolisib on Sep 11, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.